MAYNE PHARMA FDA Approval ANDA 213898

ANDA 213898

MAYNE PHARMA

FDA Drug Application

Application #213898

Application Sponsors

ANDA 213898MAYNE PHARMA

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET;ORAL5MG0AMPHETAMINE SULFATEAMPHETAMINE SULFATE
002TABLET;ORAL10MG0AMPHETAMINE SULFATEAMPHETAMINE SULFATE

FDA Submissions

UNKNOWN; ORIG1AP2020-07-14STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAA
002PrescriptionAA

CDER Filings

MAYNE PHARMA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213898
            [companyName] => MAYNE PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"AMPHETAMINE SULFATE","activeIngredients":"AMPHETAMINE SULFATE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"AMPHETAMINE SULFATE","activeIngredients":"AMPHETAMINE SULFATE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/14\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-07-14
        )

)

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